TLA in children with moderate to severe atopic eczema (TLA 4 AE)
Research type
Research Study
Full title
Temperature Controlled Laminar Airflow (TLA) treatment of moderate to severe atopic eczema in children and adolescents – a randomized placebo controlled phase 2 study
IRAS ID
252620
Contact name
Claudia Gore
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This is a single centre randomised, placebo-controlled phase 2 study in which children age 4 to 16 years with moderate to severe, longstanding allergic eczema will be enrolled.
Following a 4 to 6 week period on standardised treatment (run-in period, to ensure everyone starts with the same treatment approach), participants will be randomised to an active or dummy temperature-controlled laminar airflow (TLA) device, which has been shown to markedly reduce exposure to particles which can cause allergic reactions when being inhaled (inhaled allergens) and other particles which are in the air we breathe in. This has been shown to be an effective treatment of atopic asthma.
The participants will undergo a 12-week treatment period. The device will then be removed and a final follow-up visit occurs at 16 weeks.
REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/0196
Date of REC Opinion
28 Mar 2019
REC opinion
Further Information Favourable Opinion